Authors' objectives: Masitinib is intended to be used as second and subsequent line therapy for the treatment of moderately severe Crohn's disease, in patients who are intolerant to, or have an unsatisfactory response to immunosuppressive drugs and/or TNF-inhibitors. If licensed, it will offer an additional, oral treatment option for this patient group. Masitinib is a highly selective tyrosine kinase inhibitor that targets the c-Kit, Lyn and Fyn signalling pathways. Masitinib does not currently have Marketing Authorisation in the EU for any indication. Crohn's disease is a chronic inflammatory condition that mainly affects the gastrointestinal tract. An estimated 90,000-100,000 people in England have Crohn's disease, with around 4,500 new cases each year. It most commonly occurs in people aged between 15 and 30 years. At least 50% of people with Crohn's disease require surgical treatment in the first 10 years of disease, and approximately 70-80% require surgery within their lifetime. The clinical course is characterised by exacerbations and remission, resulting in only 75% of patients being fully capable of work in the year after diagnosis, and 15% being unable to work after 5-10 years of the disease. Around one third of patients do not respond to initial treatment with TNF-inhibitors, with a further third requiring dose escalation or a switch to a different therapy. Treatment is largely directed at reducing inflammation and relieving symptoms. Management options for Crohn's disease include drug therapy, nutrition, smoking cessation and surgery. Current pharmacological options include: glucocorticosteroids, aminosalicylates, antibiotics, thiopurines, methotrexate and TNF-inhibitors. Masitinib is currently in a phase III clinical trial comparing its effect on disease signs and symptoms against treatment with placebo.

Project Status: Completed

Year Published: 2015

URL for published report: http://www.hsric.nihr.ac.uk/topics/masitinib-for-crohns-disease-in-patients-intolerant-or-with-an-unsatisfactory-response-to-immunosuppressive-drugs-andor-tnf-inhibitors/

English language abstract: An English language summary is available

Publication Type: Not Assigned

Country: England, United Kingdom

Organisation Name: NIHR Horizon Scanning Centre

Contact Address: The NIHR Horizon Scanning Centre, Department of Public Health, Epidemiology, and Biostatistics, School of Health and Population Sciences, University of Birmingham, 90 Vincent Drive, Edgbaston, Birmingham, B15 2SP. United Kingdom. Tel: +44 121 414 7831, Fax: +44 121 2269

Contact Name: c.packer@bham.ac.uk

Contact Email: c.packer@bham.ac.uk

Copyright: NIHR Horizon Scanning Research&Intelligence Centre (NIHR HSRIC)